DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-4 and 6-20 are pending, of which claims 12-20 are withdrawn. Therefore, claims 1-4 and 6-11 are examined below.
Response to Arguments
The remarks of 10/29/2025 have been fully considered but they are not persuasive.
Applicant argues that the prior art doesn’t explicitly teach or disclose all of the elements of amended claim 1.
Applicant’s first argument is drawn to the following claim language: “wherein the outer struts overlap adjacent inner struts at pivot joints including end pivot joints joining end portions of adjacent inner and outer struts and intermediate pivot joints disposed between the end pivot joints”
In regards to this claim language: both the end pivot joints and intermediate pivot joints are shown in Fig. 4 of Barash as annotated below
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Applicant further argues that the prior art doesn’t teach the following claim language: “wherein at least some of the plurality of struts comprise recessed portions that protrude in a direction away from the valvular structure at the intermediate pivot joints, and segments of others of the plurality of struts are seated in the recessed portions at the pivot joints, the pivot joints having a generally continuous inner surface, such that inner surfaces of the seated segments and adjacent inner surfaces of the struts joined to the seated segments have about equal radial dimensions from a centerline of the frame”
Regarding this claim language Barash shows recessed portions that protrude in a direction away from the valvular structure at the intermediate pivot joint as shown below in Figs. 25 and 22
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However, Barash doesn’t explicitly teach or disclose the pivot joints having a generally continuous inner surface, such that inner surfaces of the seated segments and adjacent inner surfaces of the struts joined to the seated segments have about equal radial dimensions from a centerline of the frame”. This continuous inner surface and equal radial dimensions from the centerline is shown by Cartledge in Fig. 62 and described further in paragraph 0318.
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Therefore, claim(s) 1-4, 6, 7, 8, 9 and 11 stand as rejected over US 2018/0344456 A1 (Barash) in view of US 2013/0166017 (Cartledge). Claim 10 stands rejected over Barash in view of Cartledge further in view of US 2010/0036484 (Hariton)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6, 7, 8, 9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0344456 A1 (Barash) in view of US 2013/0166017 (Cartledge)
Regarding claim 1, Barash discloses a prosthetic heart valve (Fig. 2) comprising:
a radially expandable and compressible annular frame (Fig. 2, 22, ¶0129, “annular frame”) comprising a plurality of struts (Fig. 2, 32), the plurality of struts comprising inner struts and outer struts that are discrete from one another (¶0130, wherein 32a and 32b are discrete because they are connected at via fasteners 40 rather than integrally formed), wherein the outer struts overlap adjacent inner struts at pivot joints (¶0131, “pivot relative to one another”) including end pivot joints joining end portions of adjacent inner and outer struts and intermediate pivot joints disposed between the end pivot joints (see annotated Fig. 4 below), and radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints (¶0131); and
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a valvular structure (Fig. 2, 24) mounted within the frame that regulates blood flow through the prosthetic heart valve (¶0138, “regulate the flow of blood through the prosthetic valve”), wherein at least some of the plurality of struts comprise recessed portions that protrude in a direction away from the valvular structure at the intermediate pivot joints, and segments of others of the plurality of struts are seated in the recessed portions at the pivot joints
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Barash discloses pivot joints but doesn't explicitly teach or disclose the pivot joints having a generally continuous inner surface, such that inner surfaces of the seated segments and adjacent inner surfaces of the struts joined to the seated segments have about equal radial dimensions from a centerline of the frame
Cartledge discloses an implanted stent (Fig. 61) comprising segments seated in the recessed portions have a generally continuous inner surface (see annotated Fig. 62)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the pivot joints of Barash to have a generally continuous inner surface with equal radial dimensions from a centerline of the frame, as taught by Cartledge, to in order to prevent leakage in the valve
Regarding claim 2, the first embodiment of Barash (Fig. 2) discloses outer struts and inner struts (see rejection of claim 1) but doesn't explicitly teach or disclose wherein at least some of the outer struts comprise recessed portions and segments of at least some of the inner struts are seated in the recessed portions
The second embodiment of Barash (Figs. 21-28) discloses wherein at least some of the outer struts (Fig. 24, 1120) comprise recessed portions (see annotated Fig. 24 below) and segments of at least some of the inner struts (Fig. 25, ear 1118 on inner strut 1110) are seated in the recessed portions
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the plurality of struts of the first embodiment of Barash with recessed portions on at least some of the outer struts and segments of at least some of the inner struts seated in the recessed portions, as taught by the second embodiment of Barash, in order to form a “self-locking” pivot joint to make the prosthetic heart valve more robust (¶0224)
Regarding claim 3, the first embodiment of Barash (Fig. 2) discloses outer struts and inner struts (see rejection of claim 1) but doesn't explicitly teach or disclose Barash discloses wherein at least some of the inner struts comprise recessed portions and segments of at least some of the outer struts are seated in the recessed portions
The second embodiment of Barash (Figs. 21-28) discloses wherein at least some of the inner struts (Fig. 21, 1110) comprise recessed portions (see annotated Fig 25), and segments of at least some of the outer struts (Fig. 22, 1120) are seated in the recessed portions (see annotated Fig. 22 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the inner struts and outer struts of the first embodiment of Barash with recessed portions and segments seated in the recessed portions respectively, as taught by the second embodiment of Barash, in order to form a “self-locking” pivot joint to make the prosthetic heart valve more robust (¶0224)
Regarding claim 4, the first embodiment of Barash (Fig. 2) discloses outer struts and inner struts (see rejection of claim 1) but doesn't explicitly teach or disclose wherein at least some of the inner struts comprise recessed portions and segments of at least some of the outer struts are seated in the recessed portions
The second embodiment of Barash (Figs. 21-28) discloses wherein at least some of the inner struts comprise recessed portions that receive segments of the outer struts (see rejection of claim 3), and at least some of the outer struts comprise recessed portions that receive segments of the inner struts (see rejection of claim 2)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify both the inner struts and outer struts of the first embodiment of Barash with recessed portions to receive segments of the other strut, in order to form a “self-locking” pivot joint to make the prosthetic heart valve more robust (¶0224)
Regarding claim 6, the first embodiment of Barash (Fig. 2) discloses the pivot joints (see rejection of claim 1 above) but doesn’t explicitly teach or disclose segments are seated in the recessed portions have a generally continuous outer surface, such that outer surfaces of the seated segments and adjacent outer surfaces the strut3s joined to the seated segments have about equal radial dimensions from a centerline of the frame.
The second embodiment of Barash (Figs. 21-28) discloses where the segments are seated in the recessed portions (Fig. 22, wherein 1115 is seated in 1126) have a generally continuous outer surface (see annotated Figs. 22 and 27 below), such that outer surfaces of the seated segments (Fig. 22, wherein the outer surface of 1115 corresponds to the outer surface of the seated segments) and adjacent outer surfaces the struts joined to the seated segments (Fig. 22, wherein the outer surface of 1120 corresponds to adjacent outer surface of the strut joined to see the seated segments) have about equal radial dimensions from a centerline of the frame (see annotated Figs. 22 and 27 below)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the first embodiment of Barash with segments seated in recessed portions with a continuous outer surface and at an equal radial dimension form a centerline of the frame, as taught by the second embodiment of Barash, in order to avoid protrusions that may cause damage at the location where the frame is implanted in the body.
Regarding claim 7, the first embodiment of Barash (Fig. 2) discloses a plurality of struts and pivot joints (see rejection of claim 1) but doesn’t explicitly teach or disclose wherein at least some of the struts comprise two or more recessed portions located at respective pivot joints and segments of others of the struts are seated in the two or more recessed portions at the respective pivot joints
The second embodiment of Barash (Figs. 21-28) discloses wherein at least some of the struts comprise two or more recessed portions located at respective pivot joints (see annotated Fig. 25 below) and segments of others of the struts are seated in the two or more recessed portions at the respective pivot joints (see annotated Fig. 26 below).
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the pivot joints of the first embodiment of Barash with two or more recessed portions located at respective pivot joints and segments of others of the struts are seated in the two or more recessed portions at the respective pivot joints, as taught by the second embodiment of Barash, in order to form a “self-locking” pivot joint to make the prosthetic heart valve more robust (¶0224)
Regarding claim 8, the first embodiment of Barash (Fig. 2) discloses a frame (Fig 2, 22) comprising pins (¶0131, “pins”) but doesn't explicitly teach or disclose that the pins couple the recessed portions to the segments seated in the recessed portions at the pivot joints
The second embodiment of Barash (Figs. 21-28) discloses recessed portions (see annotated Fig. 25) and segments seated in the recessed portions at pivot joints (see annotated Fig. 26)
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It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the pivot joints with pins of the first embodiment of Barash with recessed portions and segments seated in the recessed portions, as taught by the second embodiment of Barash, in order to make the pivot joint more robust.
Regarding claim 9, Barash discloses recessed portions and segments seated in recessed portions (see rejection of claim 1) but doesn’t explicitly teach or disclose the recessed portions have a depth that is about equal to a thickness of the segments seated in the recessed portions
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Cartledge discloses wherein the recessed portions have a depth (see annotated Fig. 60 below) that is about equal to a thickness of the segments seated in the recessed (see annotated Fig. 60 below, wherein the annotated thickness and depth are about equal
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the recessed portions and segments seated in the recessed portions of Barash so that they are equal in depth and thickness respectively, as taught by Cartledge, to in order to prevent the leakage of blood through the inner surfaces of the valve
Regarding claim 11, the first embodiment of Barash discloses a frame with struts and pivot joints (see rejection of claim 1) but doesn't explicitly teach or disclose wherein at least some of the struts comprise recessed end portions and end segments of other of the struts forming pivot joints at apices of the frame
The second embodiment of Barash (Figs. 21-28) discloses wherein at least some of the struts (Fig. 22, 1120) comprise recessed end portions (see annotated Figs. 21 + 22 below) and end segments of other of the struts (Fig. 22, wherein 1110 are seated in the recessed end portions) forming pivot joints at apices of the frame (see annotated Fig. 21 below).
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Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0344456 A1 (Barash) in view of US 2013/0166017 (Cartledge), as applied to claims above, and further in view of US 2010/0036484 (Hariton)
Regarding claim 10, Barash discloses a valvular structure and struts that include recessed portions (see rejection of claim 1) but doesn’t explicitly teach or disclose that the valvular structure comprises leaflets. Cartledge doesn't explicitly teach or disclose that the valvular structure comprises leaflets
Hariton discloses an implantable prosthetic valve (Fig. 2, 10) wherein leaflets (Fig. 6, 60) of the valvular structure (Fig. 2, 14) are attached to the struts (Fig.2, wherein leaflets 60 are attached to struts 18, ¶0059).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to substitute the valvular structure of Barash in view of Cartledge with the valvular structure comprising three leaflets, as taught by Hariton, in order to replicate and replace a biological tricuspid valve
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774